Senior Scientist II- Analytical Development Lead

Responsible for establishing analytical development strategy for NBE programs in development

Responsible for project planning and execution of analytical activities to successfully drive pipeline and life cycle management of NBE projects

Represents all NBE Analytical R&D functions in global project teams

Major Responsibilities:

Coordinates all NBE Analytical R&D activities related to assigned development projects 

• Scientifically leads, oversees, guides, and coordinates the work of analytical teams to ensure successful and timely execution of NBE Analytical R&D project development activities within NBE ARD and at third party labs
• Authors NBE Analytical R&D source documents and is responsible for delivery of committed work packages of all activities assigned 
• Understands and efficiently communicates analytical project status and risks, presents data and strategies adequately
• Assess fitness for purpose of analytical test methods for quality control and characterization; works with SMEs and Centers of excellence to interpret analytical data and conclude quality relevant parameters
• Manages interaction with CROs and partner organizations; ensures SMEs are brought together as needed o Defines and Prioritizes necessary work packages 

Represents NBE Analytical R&D as single point of contact for assigned project in local and global teams 

• Establishes and applies phase appropriate scientific concepts, business workflows and standards for assigned projects in a resource responsible manner
• Translates functional development concepts into actionable strategies o Identifies and promotes opportunities to further streamline development activities across relevant interfaces and partner functions globally 
• Aligns timeline and resource needs within NBE Analytical R&D, internal, and outside partners
• Promotes harmonized analytical development strategies across NBE projects and sites o Responsible for appropriate analytical quality and risk management
• Enables learnings across programs by forcing alignment across projects and regulatory submissions
  • Establishes and continuously improves approaches related to NBE analytical development concepts across project portfolio 
• Delivers state of the art product analytical development concepts meeting regulatory expectations to promote biologics development both locally and globally 
• Drives the incorporation of knowledge of current regulations, guidances and competitive environment into decisions and strategy 
• Recognized and sought out as an expert in discipline within the company and possibly externally

• MS +7 years, or PhD +4 years in science or business related or equivalent is required - Advanced degree preferred
• Demonstrated expert knowledge and experience NBE analytical plus at least 1 more area of NBE pharmaceutical development or operations or related field 
• At least 5 years of experience in supervising or managing programs in different clinical phases 
• Strong analytical and problem-solving capabilities and skills 
• Experience in project and budget planning and execution 
• Demonstrated communication skills in English 
• Experience in a cross-functional, global environment, used to work with teams in a matrix 
• Excellent understanding of both scientific and regulatory requirements in the area of responsibility

Key Stakeholders:

• NBE Pharmaceutical Sciences functional management and SMEs 
• CMC Teams and CMC Development Program Directors 
• Technical Writing Leads, Regulatory leads, Drug Substance Leads and MSnT Leads 
• Line Management

 

 

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off. (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees  

This job is eligible to participate in our short-term incentive programs. 

This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.